Dive Brief:
- Philips Respironics has recalled bilevel positive airway pressure (BiPAP) ventilators because a false alarm can cause the devices to shut down under certain circumstances.
- The recall includes Philips’ BiPAP A30, BiPAP A40 and BiPAP V30 ventilators. Philips also began a separate recall of Omnilab Advanced Plus ventilators, which are used for titration studies.
- Philips said in a Tuesday statement that it had received 10 reports of serious injury and seven reports of patient death associated with the A30 and A40 devices between 2011 and 2023. “Investigation of these reports could not conclusively determine causation,” the company added. Philips received no reports of harm related to the V30 or Omnilab Advanced Plus units.
Dive Insight:
The latest recalls occurred just before Philips ceased selling most sleep and respiratory products in the U.S. in April, per the terms of a consent decree with the Department of Justice. The company has had a string of recalls in recent years, and it is still resolving a multi-year recall of more than 15 million sleep apnea machines and ventilators related to the breakdown of soundproofing foam used in the devices.
Philips recalled several models of ventilators in March after finding a software malfunction could cause the devices to suddenly lose ventilation. The latest recalls are separate, but include a similar alarm problem that applies to approximately 100,000 units, the company said in an emailed statement.
A ventilator inoperative alarm, which detects an internal error or condition that could affect therapy, may incorrectly engage under certain circumstances, causing the ventilator to shut down, Philips said.
The BiPAP recall began on March 26 and was posted in the Food and Drug Administration’s database on Friday. Customers can continue to use the devices according to their instructions for use. Philips said it is investigating the problem “and will implement appropriate actions to prevent recurrence.”
All of the affected V30 machines were distributed in the U.S., while most of the A30 and A40 devices were sold outside the U.S., according to the FDA notice. The recall of Omnilab Advanced Plus devices, which help determine the correct settings for sleep apnea treatment, began on April 1 and includes machines distributed in the U.S. and Canada.
